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| Sponsor: | Vancouver General Hospital |
|---|---|
| Collaborators: |
The Heart and Stroke Foundation of British Columbia and Yukon The Vancouver Coastal Health Research Institute |
| Information provided by: | Vancouver General Hospital |
| ClinicalTrials.gov Identifier: | NCT00312273 |
Purpose
The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Arrest |
Drug: Aminophylline (250mg IV +/- a second dose of 250mg IV) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial |
| Estimated Enrollment: | 966 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | July 2004 |
Out-of-hospital cardiac arrest treated by emergency medical services has an estimated incidence of 54.99 per 100,000 person years, which translates to some 155,000 episodes annually in the United States. Bradyasystole is the first recorded rhythm in up to 52 percent of cardiac arrests, and many additional patients with an initial cardiac arrest rhythm of ventricular fibrillation deteriorate to bradyasystole after defibrillation efforts. Survival to hospital discharge occurs in less than 3 percent of patients presenting with bradyasystole; however, due to its frequency, this rhythm accounts for over 17 percent of all cardiac arrest survivors. As a result, even a small improvement in survival from bradyasystolic cardiac arrest would result in thousands of lives saved annually.
Adenosine is an endogenous purine nucleoside that depresses the sinoatrial node, blocks atrioventricular conduction, inhibits the pacemaker activity of the His-Purkinje system and attenuates the effects of catecholamines. Since adenosine is produced and released by myocardial cells during ischemia and hypoxia, it may be a reversible factor in the etiology or perpetuation of bradyasystole. Aminophylline is a competitive antagonist of adenosine. The use of aminophylline for bradycardia and heart block has been described, and a number of anecdotal reports and small studies have been published on the use of aminophylline in cardiac arrest. We undertook this study to evaluate the effect of aminophylline during cardiopulmonary resuscitation (CPR) of patients with out-of-hospital bradyasystolic cardiac arrest unresponsive to initial therapy.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, British Columbia | |
| Vancouver General Hospital | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Principal Investigator: | Riyad B Abu Laban, MD, MHSc | Department of Emergency Medicine, Vancouver General Hospital |
More Information
| Study ID Numbers: | 20F35869 |
| Study First Received: | April 5, 2006 |
| Last Updated: | July 26, 2006 |
| ClinicalTrials.gov Identifier: | NCT00312273 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Heart Arrest Cardiopulmonary Resuscitation Aminophylline |
Bradycardia Humans Emergency Medical Services |
|
Respiratory System Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Enzyme Inhibitors Heart Arrest Cardiovascular Agents |
Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Autonomic Agents Therapeutic Uses Aminophylline Cardiovascular Diseases Peripheral Nervous System Agents Bronchodilator Agents |